Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ARTERIAL BUNDLE NO CATHETER, Model Number ART995; b) ART LINE KIT NO CATH, Model Number ARTNC145; c) CENTRAL LINE TRAY, Model Number CVI4705; d) CENTRAL LINE INSERTION PACK, Model Number CVI4805; e) ED CENTRAL LINE KIT, Model Number CVI4865; f) NO CATH MIDLINE INSERTION KIT, Model Number CVI4950A; g) CENTRAL LINE PROCEDURE KIT, Model Number DT22260; h) ADULT EPIV INSERTION TRAY, Model Number DYNDA2482; i) ULTRASOUND GUIDED PIV KIT, Model Number DYNDA2669; j) I.R. PICC PACK, Model Number DYNDA2759; k) IR SONO PACK, Model Number DYNDA3010; l) NEONATAL PICC LINE TRAY, Model Number DYNDC2120B; m) PICC SUPPLEMENTAL KIT, Model Number DYNDC2373A; n) CENTRAL LINE KIT, Model Number DYNDC2582A; o) CENTRAL LINE KIT UTMB, Model Number DYNDC3061; p) FNA TRAY, Model Number DYNDH1123B; q) CVL PACK, Model Number DYNJ00281O; r) CENTRAL VENOUS ACCESS PACK-LF, Model Number DYNJ0214541O; s) CENTRAL LINE PACK-LF, Model Number DYNJ0220136Q; t) PICC LINE PACK-LF, Model Number DYNJ0235859I; u) PICC LINE PACK-LF, Model Number DYNJ0235859J; v) PICC LINE PACK-LF, Model Number DYNJ0235859K; w) PICC LINE PACK, Model Number DYNJ04592K; x) PICC LINE PACK-LF, Model Number DYNJ0678523N; y) PICC LINE PACK-LF, Model Number DYNJ0855123N; z) PICC INSERTION PACK-LF, Model Number DYNJ0880659F; aa) PICC PACK-LF, Model Number DYNJ0940720D; bb) VENOUS ACCESS PACK-LF, Model Number DYNJ09895R; cc) PICC PACK-LF, Model Number DYNJ17086A; dd) VENOUS ACCESS TRAY, Model Number DYNJ20094L; ee) PICC LINE PACK-LF, Model Number DYNJ21575I; ff) CENTRAL LINE PACK, Model Number DYNJ30087C; gg) PICC LINE PACK, Model Number DYNJ30233C; hh) PICC PACK, Model Number DYNJ30566B; ii) CENTRAL LINE PLACEMENT PACK-LF, Model Number DYNJ32358G; jj) PICC TRAY, Model Number DYNJ33005F; kk) PICC TRAY, Model Number DYNJ33005G; ll) PICC LINE INSERTION TRAY, Model Number DYNJ34241; mm) PICC PACK-LF, Model Number DYNJ35000I; nn) PORT PACK, Model Number DYNJ35163C; oo) PICC TRAY-LF, Model Number DYNJ35272; pp) PICC LINE INSERTION PACK, Model Number DYNJ38868K; qq) PICC LINE INSERTION PACK, Model Number DYNJ38868L; rr) PICC ACCESSORY TRAY, Model Number DYNJ39039M; ss) CVC/PICC INSERTION PACK EH-LF, Model Number DYNJ40204B; tt) PICC INSERTION PACK MH-LF, Model Number DYNJ40206B; uu) ACCESS PICC PACK, Model Number DYNJ40682B; vv) PHOENIXVILLE VENOUS PICC TRAY, Model Number DYNJ40990C; ww) MV-IR-PICC PACK-LF, Model Number DYNJ41554C; xx) PICC TRAY, Model Number DYNJ41648; yy) CENTRAL LINE TRAY, Model Number DYNJ42902C; zz) CENTRAL LINE TRAY, Model Number DYNJ42902D; aaa) VENOUS PACK, Model Number DYNJ43168; bbb) VENOUS PACK, Model Number DYNJ43168A; ccc) VENOUS PACK, Model Number DYNJ43168B; ddd) IR CENTRAL VENOUS ACCESS, Model Number DYNJ43267G; eee) WEST VALLEY PICC LINE PACK, Model Number DYNJ43975A; fff) VENOUS LIGATION PACK, Model Number DYNJ43981G; ggg) VEIN CLOSURE TRAY - NIVC, Model Number DYNJ44737C; hhh) VENOUS ABLATION, Model Number DYNJ44904C; iii) PICC LINE PACK, Model Number DYNJ47037C; jjj) PICC LINEPACK (PCLUI)642-LF, Model Number DYNJ47717B; kkk) CENTRAL LINE PACK, Model Number DYNJ48096B; lll) PICC PACK-LF, Model Number DYNJ48120B; mmm) AV FISTULA PACK-LF, Model Number DYNJ48428C; nnn) VIEN CLOSURE, Model Number DYNJ49180A; ooo) ARTERIAL LINE PACK, Model Number DYNJ49235D; ppp) PICC PACK, Model Number DYNJ52255; qqq) PICC LINE TRAY, Model Number DYNJ52688B; rrr) PICC LINE TRAY, Model Number DYNJ52688C; sss) CENTRAL LINE INSERTION KIT, Model Number DYNJ52894A; ttt) ARTERIOGRAM PACK, Model Number DYNJ53095A; uuu) ENDOVENOUS ABLATION PACK, Model Number DYNJ53435D; vvv) MID HUDSON PICC LINE PACK, Model Number DYNJ53618A; www) MSB BEDSIDE TRAY, Model Number DYNJ54670; xxx) LEE VEIN PACK, Model Number DYNJ54906C; yyy) ARTERIOGRAM PACK, Model Number DYNJ55169G; zzz) PICC LINE PACK, Model Number DYNJ55170B; aaaa) PICC LINE PACK, M
Hazard / Issue
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
Issued by
FDA
Distribution: Nationwide (United States)
Lot/Code Info: all lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Number ART995, UDI/DI (EA) 10193489190502,UDI/DI (CS) 40193489190503; b) Model Number ARTNC145, UDI/DI (EA) 10195327306762,UDI/DI (CS) 40195327306763; c) Model Number CVI4705, UDI/DI (EA) 10193489832372,UDI/DI (CS) 40193489832373; d) Model Number CVI4805, UDI/DI (EA) 10195327068714,UDI/DI (CS) 40195327068715; e) Model Number CVI4865, UDI/DI (EA) 10195327235260,UDI/DI (CS) 40195327235261; f) Model Number CVI4950A, UDI/DI (EA) 10195327351960,UDI/DI (CS) 40195327351961; g) Model Number DT22260, UDI/DI (EA) 10653160329190,UDI/DI (CS) 40653160329191; h) Model Number DYNDA2482, UDI/DI (EA) 10193489351606,UDI/DI (CS) 40193489351607; i) Model Number DYNDA2669, UDI/DI (EA) 10193489465426,UDI/DI (CS) 40193489465427; j) Model Number DYNDA2759, UDI/DI (EA) 10193489488197,UDI/DI (CS) 40193489488198; k) Model Number DYNDA3010, UDI/DI (EA) 10195327282301,UDI/DI (CS) 40195327282302; l) Model Number DYNDC2120B, UDI/DI (EA) 10193489363357,UDI/DI (CS) 40193489363358; m) Model Number DYNDC2373A, UDI/DI (EA) 10889942492206,UDI/DI (CS) 40889942492207; n) Model Number DYNDC2582A, UDI/DI (EA) 10193489349399,UDI/DI (CS) 40193489349390; o) Model Number DYNDC3061, UDI/DI (EA) 10193489495812,UDI/DI (CS) 40193489495813; p) Model Number DYNDH1123B, UDI/DI (EA) 10193489465556,UDI/DI (CS) 40193489465557; q) Model Number DYNJ00281O, UDI/DI (EA) 10193489962963,UDI/DI (CS) 40193489962964; r) Model Number DYNJ0214541O, UDI/DI (EA) 10195327088880,UDI/DI (CS) 40195327088881; s) Model Number DYNJ0220136Q, UDI/DI (EA) 10193489823486,UDI/DI (CS) 40193489823487; t) Model Number DYNJ0235859I, UDI/DI (EA) 10193489421347,UDI/DI (CS) 40193489421348; u) Model Number DYNJ0235859J, UDI/DI (EA) 10195327069278,UDI/DI (CS) 40195327069279; v) Model Number DYNJ0235859K, UDI/DI (EA) 10195327243210,UDI/DI (CS) 40195327243211; w) Model Number DYNJ04592K, UDI/DI (EA) 10193489215205,UDI/DI (CS) 40193489215206; x) Model Number DYNJ0678523N, UDI/DI (EA) 10193489994049,UDI/DI (CS) 40193489994040; y) Model Number DYNJ0855123N, UDI/DI (EA) 10195327094881,UDI/DI (CS) 40195327094882; z) Model Number DYNJ0880659F, UDI/DI (EA) 10195327111496,UDI/DI (CS) 40195327111497; aa) Model Number DYNJ0940720D, UDI/DI (EA) 10889942550951,UDI/DI (CS) 40889942550952; bb) Model Number DYNJ09895R, UDI/DI (EA) 10195327264529,UDI/DI (CS) 40195327264520; cc) Model Number DYNJ17086A, UDI/DI (EA) 10884389064306,UDI/DI (CS) 40884389064307; dd) Model Number DYNJ20094L, UDI/DI (EA) 10195327212902,UDI/DI (CS) 40195327212903; ee) Model Number DYNJ21575I, UDI/DI (EA) 10195327009670,UDI/DI (CS) 40195327009671; ff) Model Number DYNJ30087C, UDI/DI (EA) 10889942754144,UDI/DI (CS) 40889942754145; gg) Model Number DYNJ30233C, UDI/DI (EA) 10193489382570,UDI/DI (CS) 40193489382571; hh) Model Number DYNJ30566B, UDI/DI (EA) 10889942375523,UDI/DI (CS) 40889942375524; ii) Model Number DYNJ32358G, UDI/DI (EA) 10889942526475,UDI/DI (CS) 40889942526476; jj) Model Number DYNJ33005F, UDI/DI (EA) 10193489954135,UDI/DI (CS) 40193489954136; kk) Model Number DYNJ33005G, UDI/DI (EA) 10195327319663,UDI/DI (CS) 40195327319664; ll) Model Number DYNJ34241, UDI/DI (EA) 10884389335864,UDI/DI (CS) 40884389335865; mm) Model Number DYNJ35000I, UDI/DI (EA) 10193489261646,UDI/DI (CS) 40193489261647; nn) Model Number DYNJ35163C, UDI/DI (EA) 10889942494682,UDI/DI (CS) 40889942494683; oo) Model Number DYNJ35272, UDI/DI (EA) 10884389428269,UDI/DI (CS) 40884389428260; pp) Model Number DYNJ38868K, UDI/DI (EA) 10193489657609,UDI/DI (CS) 40193489657600; qq) Model Number DYNJ38868L, UDI/DI (EA) 10195327224776,UDI/DI (CS) 40195327224777; rr) Model Number DYNJ39039M, UDI/DI (EA) 10193489898507,UDI/DI (CS) 40193489898508; ss) Model Number DYNJ40204B, UDI/DI (EA) 10195327178451,UDI/DI (CS) 40195327178452; tt) Model Number DYNJ40206B, UDI/DI (EA) 10195327176440,UDI/DI (CS) 40195327176441; uu) Model Number DYNJ40682B, UDI/DI (EA) 10889942267217,UDI/DI (CS) 40889942267218; vv) Model Number DYNJ40990C, UDI/DI (EA) 10889942024377,UDI/DI (CS) 40889942024378; ww) Model Number DYNJ41554C, UDI/DI (EA) 10889942811328,UDI/DI (CS) 40889942811329; xx) Model Number DYNJ41648, UDI/DI (EA) 10884389909171,UDI/DI (CS) 40884389909172; yy) Model Number DYNJ42902C, UDI/DI (EA) 10195327084684,UDI/DI (CS) 40195327084685; zz) Model Number DYNJ42902D, UDI/DI (EA) 10195327171100,UDI/DI (CS) 40195327171101; aaa) Model Number DYNJ43168, UDI/DI (EA) 10888277034891,UDI/DI (CS) 40888277034892; bbb) Model Number DYNJ43168A, UDI/DI (EA) 10195327084707,UDI/DI (CS) 40195327084708; ccc) Model Number DYNJ43168B, UDI/DI (EA) 10195327224523,UDI/DI (CS) 40195327224524; ddd) Model Number DYNJ43267G, UDI/DI (EA) 10195327288808,UDI/DI (CS) 40195327288809; eee) Model Number DYNJ43975A, UDI/DI (EA) 10888277882447,UDI/DI (CS) 40888277882448; fff) Model Number DYNJ43981G, UDI/DI (EA) 10193489223538,UDI/DI (CS) 40193489223539; ggg) Model Number DYNJ44737C, UDI/DI (EA) 10195327277871,UDI/DI (CS) 40195327277872; hhh) Model Number DYNJ44904C, UDI/DI (EA) 10193489858679,UDI/DI (CS) 40193489858670; iii) Model Number DYNJ47037C, UDI/DI (EA) 10193489616002,UDI/DI (CS) 40193489616003; jjj) Model Number DYNJ47717B, UDI/DI (EA) 10195327355302,UDI/DI (CS) 40195327355303; kkk) Model Number DYNJ48096B, UDI/DI (EA) 10888277939318,UDI/DI (CS) 40888277939319; lll) Model Number DYNJ48120B, UDI/DI (EA) 10888277894877,UDI/DI (CS) 40888277894878; mmm) Model Number DYNJ48428C, UDI/DI (EA) 10193489702477,UDI/DI (CS) 40193489702478; nnn) Model Number DYNJ49180A, UDI/DI (EA) 10888277863569,UDI/DI (CS) 40888277863560; ooo) Model Number DYNJ49235D, UDI/DI (EA) 10193489894332,UDI/DI (CS) 40193489894333; ppp) Model Number DYNJ52255, UDI/DI (EA) 10889942253708,UDI/DI (CS) 40889942253709; qqq) Model Number DYNJ52688B, UDI/DI (EA) 10193489452471,UDI/DI (CS) 40193489452472; rrr) Model Number DYNJ52688C, UDI/DI (EA) 10195327301026,UDI/DI (CS) 40195327301027; sss) Model Number DYNJ52894A, UDI/DI (EA) 10889942437542,UDI/DI (CS) 40889942437543; ttt) Model Number DYNJ53095A, UDI/DI (EA) 10195327148720,UDI/DI (CS) 40195327148721; uuu) Model Number DYNJ53435D, UDI/DI (EA) 10195327196448,UDI/DI (CS) 40195327196449; vvv) Model Number DYNJ53618A, UDI/DI (EA) 10889942492497,UDI/DI (CS) 40889942492498; www) Model Number DYNJ54670, UDI/DI (EA) 10889942499571,UDI/DI (CS) 40889942499572; xxx) Model Number DYNJ54906C, UDI/DI (EA) 10195327188764,UDI/DI (CS) 40195327188765; yyy) Model Number DYNJ55169G, UDI/DI (EA) 10193489967562,UDI/DI (CS) 40193489967563; zzz) Model Number DYNJ55170B, UDI/DI (EA) 10193489967579,UDI/DI (CS) 40193489967570; aaaa) Model Number DYNJ55170C, UDI/DI (EA) 10195327135355,UDI/DI (CS) 40195327135356; bbbb) Model Number DYNJ55546D, UDI/DI (EA) 10195327056520,UDI/DI (CS) 40195327056521; cccc) Model Number DYNJ56029A, UDI/DI (EA) 10195327347826,UDI/DI (CS) 40195327347827; dddd) Model Number DYNJ56857C, UDI/DI (EA) 10193489967586,UDI/DI (CS) 40193489967587; eeee) Model Number DYNJ56857D, UDI/DI (EA) 10195327280963,UDI/DI (CS) 40195327280964; ffff) Model Number DYNJ57112, UDI/DI (EA) 10889942721597,UDI/DI (CS) 40889942721598; gggg) Model Number DYNJ57793A, UDI/DI (EA) 10193489846027,UDI/DI (CS) 40193489846028; hhhh) Model Number DYNJ59246A, UDI/DI (EA) 10195327039110,UDI/DI (CS) 40195327039111; iiii) Model Number DYNJ59751B, UDI/DI (EA) 10193489695915,UDI/DI (CS) 40193489695916; jjjj) Model Number DYNJ60038A, UDI/DI (EA) 10195327038335,UDI/DI (CS) 40195327038336; kkkk) Model Number DYNJ60329A, UDI/DI (EA) 10193489972221,UDI/DI (CS) 40193489972222; llll) Model Number DYNJ60990B, UDI/DI (EA) 10193489921700,UDI/DI (CS) 40193489921701; mmmm) Model Number DYNJ62038B, UDI/DI (EA) 10193489898491,UDI/DI (CS) 40193489898492; nnnn) Model Number DYNJ62711A, UDI/DI (EA) 10193489233018,UDI/DI (CS) 40193489233019; oooo) Model Number DYNJ62889A, UDI/DI (EA) 10193489971125,UDI/DI (CS) 40193489971126; pppp) Model Number DYNJ62889B, UDI/DI (EA) 10195327030957,UDI/DI (CS) 40195327030958; qqqq) Model Number DYNJ63162, UDI/DI (EA) 10193489720891,UDI/DI (CS) 40193489720892; rrrr) Model Number DYNJ63213, UDI/DI (EA) 10193489728217,UDI/DI (CS) 40193489728218; ssss) Model Number DYNJ63268C, UDI/DI (EA) 10195327077167,UDI/DI (CS) 40195327077168; tttt) Model Number DYNJ63268D, UDI/DI (EA) 10195327132217,UDI/DI (CS) 40195327132218; uuuu) Model Number DYNJ63268F, UDI/DI (EA) 10195327297114,UDI/DI (CS) 40195327297115; vvvv) Model Number DYNJ63590, UDI/DI (EA) 10193489769180,UDI/DI (CS) 40193489769181; wwww) Model Number DYNJ64141A, UDI/DI (EA) 10195327279578,UDI/DI (CS) 40195327279579; xxxx) Model Number DYNJ64190B, UDI/DI (EA) 10195327281281,UDI/DI (CS) 40195327281282; yyyy) Model Number DYNJ64249A, UDI/DI (EA) 10193489381368,UDI/DI (CS) 40193489381369; zzzz) Model Number DYNJ64337, UDI/DI (EA) 10193489800289,UDI/DI (CS) 40193489800280;